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United States · US · US:67979-511_da249940-81ef-4af3-8c59-4697e0404e71

Aveed

In shortageOrange BookUNIISPLATC G03BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeG03BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6797951143
    1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) / 3 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
H16A5VCT9C
TESTOSTERONE UNDECANOATE
RxCUI 37864
Orange Book
N022219
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
  "unii": {
    "unii": "H16A5VCT9C",
    "rxcui": "37864",
    "inchikey": "UDSFVOAUHKGBEK-CNQKSJKFSA-N",
    "display_name": "TESTOSTERONE UNDECANOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "f80f025b-17d8-40af-8739-20ce07902045": {
      "match": "brand_token",
      "title": "AVEED (TESTOSTERONE UNDECANOATE) INJECTION [ENDO USA, INC.]",
      "spl_version": "45",
      "published_date": "2026-03-18"
    }
  },
  "productid": "67979-511_da249940-81ef-4af3-8c59-4697e0404e71",
  "productndc": "67979-511",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022219",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "750MG/3ML (250MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 5, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TESTOSTERONE UNDECANOATE",
  "shortage_reason": "Testosterone Gel; Gel, Metered",
  "shortage_status": "current",
  "proprietary_name": "Aveed",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022219",
  "marketing_category": "NDA",
  "nonproprietary_name": "testosterone undecanoate",
  "start_marketing_date": "20140305",
  "active_numerator_strength": "250"
}

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